BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1903430 · Received November 19, 2010

    Report

    Report Number
    3005099803-2010-04822
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-SURGICAL MEDICAL INTERVENTION REQUIRED. (B)(4) - STENT MIGRATED. (B)(4) - STENT BLOCKED/OCCLUDED DUE TO TISSUE INGROWTH. SINCE THE COMPLAINT DEVICE REMAINS IMPLANTED, IT WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED ON (B)(6) 2010 TO TREAT METASTATIC OVARIAN CANCER WHICH HAD PROGRESSED INTO THE COLON. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE (EXACT DATE UNKNOWN), THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF PAIN AND BLEEDING FROM THE RECTUM. IT WAS THEN DISCOVERED THAT THE WALLFLEX STENT HAD MIGRATED INTO THE RECTUM. THE PHYSICIAN MADE AN ATTEMPT TO REMOVE THE STENT; HOWEVER, DUE TO TISSUE INGROWTH, THE STENT COULD NOT BE SAFELY REMOVED. SINCE THIS TIME, THE PATIENT HAS BEEN TREATED WITH CHEMOTHERAPY, WHICH CAUSED THE TUMOR TO SHRINK IN SIZE. THE PATIENT'S SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. ALTHOUGH THE PHYSICIAN DOES PLAN TO REMOVE THE STENT, AT THE CURRENT MOMENT, THE STENT REMAINS IMPLANTED AND NO ADDITIONAL PROCEDURES HAVE BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565060 0012070082

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention